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Effect of Propofol and Sevoflurane on Lactate During Anesthesia for Pediatric Heart Catheterisation (PRISCATHLAB)

This study has been completed.
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01293266
First received: February 9, 2011
Last updated: March 10, 2011
Last verified: February 2011
History of Changes

February 9, 2011
March 10, 2011
June 2009
August 2010   (final data collection date for primary outcome measure)
Serum Lactate [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Serum lactate is measured during application of propofol and sevoflurane to examine the effect on metabolic acidosis.
Same as current
Complete list of historical versions of study NCT01293266 on ClinicalTrials.gov Archive Site
pH and base excess [ Time Frame: Hours ] [ Designated as safety issue: No ]
pH and base excess are measured during application of Propofol and Sevoflurane to examine the effect on acid-base balance
Same as current
Not Provided
Not Provided
 
Effect of Propofol and Sevoflurane on Lactate During Anesthesia for Pediatric Heart Catheterisation
Effect of Propofol and Sevoflurane on Base Excess, pH and Lactate in Pediatric Heart Catheterisation

Propofol is routinely used for general anesthesia during pediatric heart catheterisation. Propofol infusion syndrome (PRIS) is a rare, but often fatal complication mainly defined by bradycardia with progress to asystolia during propofol infusion. Metabolic acidosis is regarded as an early warning sign of PRIS. In this study the effect of propofol and sevoflurane on serum base excess, pH and lactate are examined during pediatric heart catheterisation.

In this prospective randomised study 40 children are anesthetised for pediatric heart catheterisation with propofol (N = 22) or sevoflurane (N = 18) with ethic committee approval. Base excess, pH and lactate were measured by blood gas analysis at the beginning, during and at the end of the procedure. Changes relative to baseline were analysed by paired t-Test with correction for multiple testing. The study was powered to detect a difference of 1.5 mmol/l for base excess and lactate.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Metabolic Acidosis
Drug: Propofol
Anesthesia is switched from sevoflurane to propofol after obtaining a baseline blood gas analysis.
Other Name: Disoprivan
  • Active Comparator: Propofol
    Anesthesia is changed from Sevoflurane to Propofol after obtaining baseline blood gas analysis from the heart catheterisation sheath.
    Intervention: Drug: Propofol
  • No Intervention: Sevoflurane
    Sevoflurane anesthesia is maintained after obtaining a baseline blood gas analysis.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Indication for heart catheterization under general anesthesia

Exclusion Criteria:

  • Participation in another study
  • Preexisting metabolic acidosis
  • Contraindication against Propofol
Both
up to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01293266
Fudickar2
No
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
University of Schleswig-Holstein
Not Provided
Study Director: Berthold Bein, Prof. Dr. University Hospital Schleswig-Holstein, Campus Kiel
University of Schleswig-Holstein
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP